Spine Feature

3D Printed Sternum/Ribcage Implanted in Surgical First

Biloine W. Young • Wed, October 25th, 2017

Medical history is made when brave surgeons encounter equally brave patients. The patient in his case is 20-year-old Penelope Heller. Leading the surgery on Heller was Jeffrey L. Port, M.D, attending cardiothoracic surgeon at New York Presbyterian /Weill Cornell Medical Center.

Port undertook the operation to revise a prior sternum/ribcage removal and reconstruction done in 2014. The patient had undergone the original procedure to remove a malignant bone tumor that was resistant to chemotherapy.

Doctors successfully removed the cancer in the first surgery and installed an off-the-shelf implant for the patient. However Heller continued to experience pain and difficulty breathing.

As she explained, “With a long active life ahead of me I wanted to participate in activities that I love fully and without pain. Electing to have this procedure was a big decision and I’m coming forward to empower other people in the same situation.”

The surgery, performed on August 2, 2017, replaced the sternum and partial ribcage using a custom 3D printed composite titanium/porous polyethylene implant.

It was the first time that this technology was used in the United States and only the second time in the world that a 3D printed composite sternum and rib cage had been implanted. The implant was used under the FDA’s Expanded Access (Compassionate Use) Program.

Researchers designed the implant using high resolution CT scans of the patient’s chest that were sent to Anatomics Pty Ltd engineers. Port reviewed and confirmed the design before it was sent to Australia’s Commonwealth Scientific and Industrial Research Organization’s printing laboratory.

Heller’s custom sternum implant became the second in the world to also use Australia’s Porestar technology, a proprietary porous polyethylene material with bone-like architecture.

Porestar is currently awaiting FDA marketing approval.

Anatomics executive chairman Paul D’Urso, said, “The patient’s story is one of many but what makes it truly remarkable is how the patient and her family, Dr. Port and the staff at New York Presbyterian/Weill Cornell, Anatomics and the FDA came together to make this story a reality. It was a group effort that began with the patients pursuit of information.”

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Lumbar Spine Surgery in Parkinson’s Patients: Good Results

Elizabeth Hofheinz, M.P.H., M.Ed. • Fri, October 30th, 2015

Researchers from New York and Israel have taken on an unusual topic…lumbar spine surgery in patients with Parkinson’s disease. The investigators, from Hadassah Hebrew University Medical Center in Jerusalem, and Beth Israel Medical Center and Hospital for Special Surgery (HSS) in New York City, found that Parkinson’s patients fared well after undergoing lumbar spine surgery, and experienced a decrease in pain.

According to the study, the team identified 96 patients who underwent lumbar spine surgery between 2002 and 2012. Of these, 72 had spinal stenosis, 17 experienced spondylolisthesis, and 7 suffered from coronal and/or sagittal deformity. The visual analog scale for back pain improved from 7.4 cm preoperatively to 1.8 cm postoperatively. The visual analog scale for lower-limb pain improved from 7.7 cm preoperatively to 2.3 cm postoperatively. The Oswestry Disability Index score dropped from 54.1 points to 17.7 points at the time of the latest follow-up.

Josh Schroeder, M.D., an orthopedic surgeon with Hadassah Hebrew University Medical Center, told OTW, “The study was prompted by several patients who suffered from Parkinson’s disease. We tried to locate existing data on the topic, but could not find any large study on Parkinson’s, despite this being a disease that affects 5% of the elderly population.”

“I was surprised to see that most patients do well after surgery. Sometimes less is more, and doing a smaller surgery might be better for the patient. Ours is the first large study on Parkinson’s patients, and it taught us to divide the patients into groups from mild to severe Parkinson’s disease.”

“In the future, a large prospective study is mandated, if possible to include neurodegenerative diseases such as muscular dystrophy and more. The important message is, ‘See the patient, tailor the procedure to the patient and understand that input from a neurologist is critical.’”

First Meniscus Replacement in SUN Trial Completed

Elizabeth Hofheinz, M.P.H., M.Ed. • Tue, May 31st, 2016

Salt Lake Regional Medical Center, in conjunction with Active Implants, LLC, announced that the first meniscus replacement in the SUN (Safety Using NUsurface) clinical trial has been performed by Andrew Cooper, M.D. This is the only hospital in Utah—and one of just 10 sites nationwide—enrolling patients with persistent knee pain caused by injured or deteriorating meniscus cartilage in the SUN trial. This trial is designed to assess the safety and effectiveness of the NUsurface Meniscus Implant in restoring function similar to that of a natural, healthy meniscus.

According to the May 19, 2016, news release, “The recipient of the implant was 55-year-old Uintah resident Kent Carlson, who has experienced meniscus-related problems since he was a child as a result of skiing injuries. He underwent a meniscectomy and has been getting cortisone shots, but the pain has persisted to the point where sitting for long periods or bearing weight are uncomfortable. Even low-impact exercises like swimming and cycling can cause his knee to swell.”

“There aren’t many options for patients like Kent, who experienced persistent knee pain following meniscus surgery, ” said Dr. Andrew Cooper, orthopedic surgeon at Salt Lake Regional Medical Center. “Damage to the meniscus can lead to arthritis and the need for knee replacement surgery. We hope the NUsurface implant alleviates pain in these patients, as well as helps them delay or avoid knee replacement surgery.”

The NUsurface Meniscus Implant is inserted into the knee joint through a small incision and patients typically can go home soon after the operation. After surgery, they undergo a six-week rehabilitation program. The NUsurface Meniscus Implant has been used in Europe under CE Mark since 2008 and in Israel since 2011.

The SUN study (Safety Using NUsurface) will enroll approximately 120 patients as part of the regulatory process to gain approval from the FDA to sell the device in the U.S.

Dr. Cooper told OTW, “The most interesting part of being an investigator in the SUN study is working with an international team of developers and researchers to bring this groundbreaking technology to the U.S. I have a high volume of patients who are very active and are in need of a new treatment option for persistent knee pain following meniscectomy.

Same Day Joint Replacement a Hit

Biloine W. Young • Mon, August 3rd, 2015

Imagine “going to sleep with chronic joint pain, waking up with no pain and walking out of the hospital on the same day, ” wrote Anaka Ucheghu for the Pittsburg Post Gazette. She was writing about a program at West Penn Hospital of the Allegheny Health Network

Ucheghu quoted Nick Sotereanos, M.D., the orthopedic surgeon who performed Allegheny Health Network’s first same-day hip replacement as saying, “This is phenomenal, and it’s because of the baby boomers. There is a huge economic push to make this procedure less expensive and quicker.”

A year and a half ago, for carefully selected patients, Allegheny Health Network began offering same-day total hip replacements. In May, surgeons performed the first same-day total knee replacement at Allegheny General Hospital.

Michael Seel, M.D., director of orthopedic surgery at West Penn Hospital said that good candidates for same-day joint replacements are in their 60s or younger and do not have any other medical problems, such as heart disease. Patients are discharged only if they can walk with assistance between 40 and 75 feet, can get out of bed, use the bathroom, and go up and down a flight of stairs unassisted.

Ucheghu reported that John Meeker, 51, was the first to experience Allegheny Health Network’s same-day total knee replacement operation. Meeker said that his recovery has been smooth. “Three hours after the surgery I was walking down the hall with a walker, and they let me go the same day.” He added that he had not felt groggy or in pain when he woke up.

Seel said the surgical technique is the same for same-day patients and overnight patients. But improved surgical and pain management techniques have enabled some patients to avoid a night in the hospital.

Doctors quoted by Ucheghu said that managing pain and the side effects of narcotic painkillers is one of the main factors behind the need for overnight hospitalization.

Surgeons at Allegheny Health Network say that they have made hip replacements less painful by approaching the hip from the front and not cutting into the thick muscle behind, and at the side of the hips.

Cartiva: First OP Procedure With Synthetic Cartilage Implant

Elizabeth Hofheinz, M.P.H., M.Ed. • Fri, July 22nd, 2016

Cartiva, Inc. has announced that the first commercial U.S. patient has received the Cartiva Synthetic Cartilage Implant (SCI) following its approval by the U.S. Food and Drug Administration (FDA) on July 1. According to the July 12, 2016 news release, “The Cartiva SCI device is intended for use in the treatment of patients with painful arthritis at the base of the big toe, the most common arthritic condition in the foot. The outpatient procedure was performed by Judith F. Baumhauer, M.D. at University of Rochester Medical Center’s Sawgrass Surgery Center.”

“Today, one in 40 Americans over the age of 50 experience arthritis of the toe, and with the aging population, that number is likely to grow. This condition can be particularly life-impacting—limiting a person’s ability to conduct functional activities of daily living, producing pain and discomfort and restricting shoe wear options, ” said Dr. Baumhauer. “The Cartiva implant was accomplished in a quick, simple surgical procedure and we look forward to offering this innovative option to more people in need.”

Dr. Baumhauer told OTW, “What I found very interesting and surprising during my first Cartiva Synthetic Cartilage Implant (SCI) procedure was how smoothly it all came together. As a surgeon, you always go in expecting the first procedure to take a little extra time or require some fussing or tweaks to be done. In this case, the Cartiva implant was easily inserted and on X-ray it visibly sat proud in the joint—exactly as it is designed to provide optimal comfort and minimize friction in the joint. In surgery, you don’t expect the first procedure to go off without a hitch and the smoothness of this procedure was surprising. Now, I am excited to find more patients who can benefit from the Cartiva implant.”

Regarding the recent FDA process, Cartiva President and CEO Timothy J. Patrick told OTW, “The most interesting part of the process was the set-up and conducting of the clinical trial. The Cartiva MOTION clinical study was the largest study ever undertaken for arthritis of the great toe joint. This gave us an opportunity to work with 20 of the top foot and ankle surgeons at 12 sites in Canada and the United Kingdom.

Illinois Surgeon Does Outpatient Hip Replacement

Biloine W. Young • Fri, January 9th, 2015

Shawn W. Palmer, M.D., of Midwest Bone and Joint Institute at the Valley Ambulatory Surgery Center (ASC), in St. Charles, Illinois, has performed the state’s first outpatient anterior approach hip replacement surgery.

According to PR Newswire, during surgery the hip is replaced from the front side without cutting any muscle. This is said to allow patients to go home just hours after receiving the procedure. They resume normal activities such as driving a car within just a few days.

The contrast with patients who undergo traditional hip replacement surgery is dramatic. They usually spend up to four days in the hospital recovering, experience more post-operative pain, and may require extended therapy. The cost difference is substantial. When performed in an ambulatory surgery center, the hip replacement surgery costs up to 66% less, thus potentially saving patients thousands of dollars.

"Patients not only experience less pain and recover better at home, but also appreciate the dramatic reduction in cost as many begin to bear more responsibility for their own healthcare expenses, " said Palmer. "We're pleased to be among just a handful of providers throughout the country offering this life-changing surgery in an ASC setting."

Not every patient is a candidate for outpatient surgery. One who was is Betsy Evett of Santa Rosa Beach, Florida. PR Newswire quotes her saying, "I was walking within three hours of surgery and off my pain medication after two days. The cost difference was substantial; I saved more than half the cost of having the procedure done at my local hospital, yet received first-class care."

Palmer, who has been installing new hips in a hospital setting for five years, credits the advances in pain control and minimally-invasive surgery, with making it possible to offer this type of surgery in an out-patient setting.